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NCT Number: NCT06144112

Fibrinogen Concentrates Versus Cryoprecipitate in Liver Transplant Surgery

We compared the time consumed for goal-directed management of hypofibrinogemia using two strategies during liver transplant (LT) surgery: a conventional cryoprecipitate-based strategy versus a lyophilized fibrinogen concentrate-based strategy

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Key information

Conditions

Liver Diseases Cardiovascular Diseases Digestive System Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Vascular Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

The primary outcome is an inter-group comparison of treatment time (T-time, the duration from ordering cryoprecipitate or FC to completing its administration). The secondary measures include comparisons of perioperative bleeding, blood transfusion, coagulation profiles, reoperation, thromboembolic complications, mortality, oxygenation profiles, fibrinolysis phenotypes, and costs for bleeding management and length of hospital stay.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Liver disease undergoing Liver transplantation

Exclusion criteria

-

Treatment and study plan

fresh frozen plasma

Biological

transfusion of fresh frozen plasma

prothrombin complex concentrate

Biological

prothrombin complex concentrate administration

Primary outcomes

  1. intergroup difference in the treatment time (T-time)

    Time frame: 1 min

    The treatment time (T-time): the duration from ordering cryoprecipitate or FC to completing its administration

Secondary outcomes

  1. Red Blood Cell amount

    Time frame: 1 hour

    Red Blood Cell transfusion amount during surgery

  2. FFP amount

    Time frame: 1 hour

    FFP transfusion amount during surgery

  3. Platelet amount

    Time frame: 1 hour

    Platelet transfusion amount during surgery

  4. r-time

    Time frame: 1 min

    CK r-time after PCC or FFP

  5. CRT-MA

    Time frame: 1 min

    CRT-MA after PCC or FFP

  6. CFF-MA

    Time frame: 1 min

    CFF-MA after PCC or FFP

  7. Bleeding

    Time frame: 6 hour

    Postoperative bleeding amount

  8. oxygenation profile

    Time frame: 1 hour

    PaO2/FiO2 ratio

  9. preparation time of cryoprecipitate or FC

    Time frame: 1 min

    time from the start of preparation (ABO-cross matching and thawing of cryoprecipitate or unpacking FC from its storage) to the delivery to patients in the operation theater

Study contacts

Contact information is provided by the study sponsor or research team.

Tae-Yop Kim, MD PhD

CONTACT

[email protected]

+82-10-8811-6942

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Collaborators

  • Samsung Medical Center

Registry information

Official study title

A Randomized Trial Comparing the Time for Managing Intraoperative Hypofibrinogenemia Using Fibrinogen Concentrates Versus Cryoprecipitate in Liver Transplant Surgery (FIBCRYO-LT Trial)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 22, 2023
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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